The Summary of Product Characteristics (SPC or SmPC) is a specific document, the wording of which has been agreed with the regulatory authority as part of the medicine approval process. It is required before any medicine is allowed on the market in Europe. It is designed to assist doctors and pharmacists in prescribing and supplying the product.

Free text change information supplied by the pharmaceutical company

Updated on 23 October 2017 SmPC

Reasons for updating

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 23 October 2017 SmPC

Reasons for updating

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

A Type IA Variation was submitted to change the name of product manufacturer & batch release site registered on the licence.

Section 10 change of date of revision from August 2017 to October 2017

Updated on 19 October 2017 PIL

Reasons for updating

New PIL for new product

Updated on 19 October 2017 PIL

Reasons for updating

Change to section 6 - date of revision

Updated on 18 August 2017 SmPC

Reasons for updating

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

10. DATE OF REVISION OF THE TEXT February 2015 changed to August 2017

Updated on 18 August 2017 PIL

Reasons for updating

Change to section 6 - manufacturer

Change to section 6 - date of revision

Updated on 1 June 2015 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.8 - Undesirable effects

Change to Section 4.8 – Undesirable effects - how to report a side effect

Change to section 6.5 - Nature and contents of container

Change to section 8 - MA number

Change to section 10 - Date of revision of the text

Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 – Hepatic and renal impairment – The safety of caffeine citrate in patients with renal impairment has not been established – has been removed

Section 4.4 – Renal and hepatic impairment - In a post-authorisation safety study, the frequency of adverse reactions in a small number of very premature infants with renal/hepatic impairment appeared to be higher as compared to premature infants without organ impairment – has been added

(see sections 4.2,4.8 and 5.2) has been amended to add 4.8

Section 4.8 – and - had been removed

Convulsion, arrhythmia, metabolism and nutrition disorders such as hyperglycaemia, and obtained from a post-authorisation safety study – has been added

Changes to the side effects table include – Hyperglycaemia , common

Hyperglycaemia changed to Hypoglycaemia

Convulsion, Uncommon

Convulsion removed from frequency unknown

Tachycardia , common

Arrhythmia, Uncommon

Tachycardia also associated with – removed

New section added - Other special populations

In a post-authorisation safety study on 506 preterm infants treated with Peyona, safety data have been collected in 31 very premature infants with renal/hepatic impairment. Adverse reactions appeared to be more frequent in this subgroup with organ impairment than in other observed infants without organ impairment. Cardiac disorders (tachycardia, including one single case of arrhythmia) were mostly reported.